Leader Throat Soothing Drops Creamy Strawberry Lozenge
FDA Label NDC 70000-0711
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Throat Soothing Drops Creamy Strawberry (NDC 70000-0711). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (per drop), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (Per Drop)
Pectin 7 mg
Purposes
oral demulcent
Uses
For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat
Warnings
Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Directions
• adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. • children under 5 years of age: ask a doctor.
Other Information
• Store at room temperature • keep away from excessive heat or sunlight • do not use if primary bag seal has been torn or broken • contains: SOY.
Inactive Ingredients
beta carotene, citric acid, corn syrup, FD&C blue 2, FD&C red 40, lactic acid, malic acid, potassium citrate, soy lecithin, strawberry flavor, sucrose, sucralose, titanium dioxide, water.
Questions?
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